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The Patented Medicines Price Review Board (PMPRB) is an independent, quasi-judicial body that regulates the maximum amount that companies can charge for their medicines in Canada. The PMPRB sets the maximum price that can be charged for medicines in Canada.
When a drug comes to Canada it must go through the Canadian drug regulatory, review and reimbursement system. The drug must go to various review bodies before it is eligible for public reimbursement. It must first be approved by Health Canada for safety, efficacy, and quality, then goes to the PMPRB before public and private reimbursement is negotiated and the drug is listed on health plans.
One of Cystic Fibrosis Canada’s key advocacy priorities is to create a regulatory and reimbursement environment in Canada that does not unnecessarily limit our access to existing and new life-saving therapies. See more information about CF Canada’s work to help build a fast and fair process for access to medicines in Canada.
In May of 2017, Health Canada proposed changes to the Patented Medicines regulations. These changes incorporated new factors in determining whether a medicine is being or has been sold at an “excessive” price.
Since the changes to the regulations were first proposed, the patient community has consistently raised concerns that these changes will negatively impact access to new medicines for Canadian patients.
The new PMPRB regulations require patented drug manufacturers to significantly reduce their prices. By some estimates, these changes will require reductions in price as high as 75%, but the actual reductions depend on a number of assumptions that themselves are creating uncertainty. Upon implementation, Canada will become an outlier among OECD countries and a much less attractive market in which to launch innovative therapies, including precision medicines that can alter the course of devastating diseases like cystic fibrosis.
The impact of these regulatory changes:
The PMPRB, and the federal government, have repeatedly assured patient groups that access to new medicines will not be impacted by the proposed regulatory changes.
On February 14, 2020, Cystic Fibrosis Canada called on the federal government to halt implementation of regulatory changes to the PMPRB
Changes to the comparator countries used by the PMPRB are deemed acceptable, but changes aimed at further reducing prices are creating an uncomfortable uncertainty and could make Canada an outlier amongst OECD countries, and a less desirable destination for drug manufacturers. They put access to game-changing medicines like Trikafta at risk and should be evaluated by an independent third party to avoid unintended negative consequences to patients.
On June 19, 2020, the Government of Canada released updated draft guidelines to the regulations of the PMPRB. The PMPRB commented they had received nearly 900 letters from members of the CF community in an advocacy initiative spearheaded by CF Canada.
While Cystic Fibrosis Canada welcomed the revisions to the draft guidelines and supports pricing controls as a means to improve accessibility, these PMPRB guidelines have gone too far and could continue to create an environment that discourages manufacturers from bringing life-changing CF medicines to Canada. There are some provisions in the guidelines that could be promising for Trikafta, but we aren’t confident they are good enough.
Cystic Fibrosis Canada submitted a response to the revised draft guidelines on July 28, 2020. In addition, the CF community sent the PMPRB over 1,850 letters supporting Cystic Fibrosis Canada's submission on the revised PMPRB guidelines.
Cystic Fibrosis Canada held a Q&A webinar session focused on the PMPRB, our response to the revised draft guidelines and what they might mean for access to life-changing CF medications.
Watch the recording:
On October 23, 2020, the PMPRB released an updated version of the revised guidelines. We were disappointed that the new guidelines do not appear to have factored in any of Cystic Fibrosis Canada’s recommendations that were submitted during the guidelines consultation process, nor do they keep patient voices at the centre. While the new guidelines do recognize that an evaluation process is needed for the future, the details are vague and don’t outline the inclusion of patients. We continue to call on the government to revisit these guidelines and find a needed balance between lower drug prices and access to innovative medicines remains lacking.
In June 2021, the PMPRB announced another six month delay to the implementation of the revised guidelines. The guidelines are now due to take effect on January 1, 2022.
Please visit our #CFcantwait page to find out how you can be involved with our work to ensure Canadians with cystic fibrosis have fast and fair access to new medicines.